Key Highlights
- FDA 510(k) clearance granted to CLEW Medical for its advanced AI/machine-learning models.
- Built on proprietary models, the platform significantly reduces alarms, enhancing clinical care.
- Peer-reviewed study confirms the platform’s predictions are five times more accurate than leading systems.
Source: Business Wire
Notable Quote
- “At CLEW, we understand the significance of using AI to enhance care for critically ill patients. We are committed to fostering trust among caregivers, while offering them the most sophisticated and accurate clinical predictions available on the market by adhering to the most stringent regulatory processes.” – Paul Roscoe, CEO at CLEW Medical
SoHC's Take
This new FDA clearance for CLEW Medical not only reinforces the credibility of AI and machine-learning in critical healthcare applications but also underscores the industry’s commitment to rigorous safety and performance standards. As AI technologies continue to evolve, such regulatory milestones are essential for integrating these advancements into clinical settings effectively. The impact on patient care is profound, offering earlier interventions and reducing system burdens, which is crucial in high-stakes environments like intensive care units.
